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Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.

Minimal Invasive Imaging of Coronary Artery Disease in Patients With Asymptomatic Myocardial Injury After Major Non-cardiac Surgery.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960309
Acronym
AMI-NCS
Enrollment
70
Registered
2013-10-10
Start date
2012-09-30
Completion date
2015-08-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardium; Injury

Brief summary

This is a cross-sectional pilot study to assess coronary artery disease with minimal invasive techniques in patients with asymptomatic troponin elevation after noncardiac surgery. The primary objective is to quantify coronary artery disease, as determined by coronary CT and MR, as a cause of postoperative myocardial injury. The secondary objective is to correlate coronary calciumscore to postoperative levels of troponin.

Interventions

OTHERMinimal invasive cardiac imaging

* Coronary CT angiography (CCTA) * Coronary magnetic resonance imaging (CMR) * Echocardiography

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Major noncardiac surgery with a planned minimal postoperative hospital stay of 2 days * Age \> 59 years * Troponin\_I elevation \> 0.06 ng/ml in the first 3 post-operative days * No clinical symptoms of myocardial ischemia

Exclusion criteria

* Perioperative troponin elevation due to other factors than coronary artery disease such as proven pulmonary embolism or sepsis * Perioperative ST-elevation myocardial infarction (STEMI) * Perioperative symptomatic angina with troponin elevation * Patients with a history or ECG-signs of myocardial infarction * Patients with pre-existent heart failure, left ventricular dysfunction, significant valvular disease or left ventricle hypertrophy * Patients with significant valvular disease or left ventricle hypertrophy determined postoperatively with echocardiography. * Contra-indication for CMR such as claustrophobia or metal prosthesis * Allergic reaction to CT-contrast or gadolinium * Renal dysfunction with GFR \< 50 ml/min, as determined after the operation * Unstable hemodynamics or other conditions disabling transport to the Radiology department * Expected major discomfort or substantial increase in pain sensation by undergoing CCTA or CMR * Admission at the ICU * Poor prognosis due to other medical conditions e.g. malignancy

Design outcomes

Primary

MeasureTime frameDescription
Coronary artery diseaseDuring hospital admissionCoronary artery disease with luminal narrowing \> 50 % in one or more major epicardial vessels by CCTA.

Secondary

MeasureTime frameDescription
Coronary calcium scoreDuring hospital admissionAgatston coronary calcium score
Extent of coronary artery atherosclerosisDuring hospital admissionPresence and extent of coronary artery atherosclerosis as measured with coronary CCTA
Minimal myocardial injuryDuring hospital admissionMinimal myocardial injury measured by late gadolinium enhancement on CMR.

Countries

Netherlands

Contacts

Primary ContactHendrik M. Nathoe, MD PhD
H.M.Nathoe@umcutrecht.nl+31 88 755 7273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026